A Study of Cesium-131 Brachytherapy Following Sub-Lobar Resection for Early Stage Non Small Cell Lung Cancer

NCT ID: NCT01237171

Last Updated: 2021-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2010-11-30

Brief Summary

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For patients diagnosed with early (Stage I) non-small cell lung cancer, a lobe of lung is usually removed at surgery to treat the cancer. For some patients, the removal of a lobe of lung may leave too little lung behind for easy breathing. For some of these patients, it may be possible to perform a smaller-scale surgery ("sub-lobar resection") and place a radioactive implant behind to prevent the cancer from growing back. This study will see how these patients do in terms of controlling their disease treated with a radioactive implant called Cesium-131.

Detailed Description

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Conditions

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NSCLC Non Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sub-lobar resection with Cesium-131

All enrolled patients will undergo sub-lobar resection and brachytherapy implant with Cesium-131 in an effort to study and quantify recurrence/control patterns.

Cesium-131 Brachytherapy Seed

Intervention Type RADIATION

85 Gray Dose

Interventions

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Cesium-131 Brachytherapy Seed

85 Gray Dose

Intervention Type RADIATION

Other Intervention Names

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Sealed Brachytherapy Source CS-1 (IsoRay Medical)

Eligibility Criteria

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Inclusion Criteria

1. Patients must have suspicious lung nodule for clinical stage I/recurrent non-small cell Lung Cancer
2. Mass Tumor size \< 7 cm
3. Patient must have a CT scan of the chest with upper abdomen within 90 days prior to date of pre-registration.
4. Patient must have ECOG/Zubrod performance status 0,1, or 2.

Exclusion Criteria

1. Patient has already received high dose radiation to the area
2. Cancerous nodule is very close to the esophagus or spinal cord, thereby increasing the risk of radiation treatment
3. Pregnancy or unwillingness to practice a form of birth control (i.e. abstinence, oral contraceptives, etc.)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IsoRay Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bhupesh Parashar, M.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Cornell Medical College

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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Cs131-Lung001

Identifier Type: -

Identifier Source: org_study_id

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